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news.US-based Regenerx Biopharmaceuticals has completed enrollment and dosing of 40 healthy volunteers for its Phase Ib double-blind, placebo-controlled clinical trial testing RGN-352, an injectable formulation of Tß4 for potential use in treating acute myocardial infarction patients or heart attack.
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The trial included four groups of 10 subjects each to assess the safety and tolerability of escalating doses of RGN-352 injected daily into the blood stream over a 14-day period. To date, RGN-352 appears safe and well-tolerated. A final analysis and report will be submitted to the FDA in approximately 180 days.
Previously, RegeneRx completed its Phase Ia trial in which a single dose of RGN-352, escalating over increasing concentrations, was deemed to be safe and well-tolerated.
David Crockford, vice president of clinical and regulatory affairs at RegeneRx, said: “Completing enrollment and dosing of the final part of our Phase I trial is a very important milestone. Although we will submit a final report in six months, thus far RGN-352 appears to be safe and well-tolerated at all doses studied.
“Based on these data we are prepared to concentrate on our Phase II cardiovascular program and how best to implement a study whose objective is to prevent and repair damage to the heart after a heart attack. Other potential uses of RGN-352 in conditions where short-term systemic administration of the drug candidate may be warranted will also be evaluated.”